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The Fair Pricing Coalition (FPC) today expressed disappointment at the price Janssen Therapeutics set for Olysio (simeprevir), a second generation protease inhibitor (PI) approved by the U.S. Food and Drug Administration on November 22, 2013 for the treatment of chronic hepatitis C (HCV) in genotype 1 patients. Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360. Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

“While we are very excited to have more effective and more tolerable treatment options for people living with hepatitis C, we are concerned about the overall cost of treatment,” said FPC HCV Co-Chair Lorren Sandt. “Janssen did price Olysio comparatively with other HCV PIs, but the bar previously had been set too high. We strongly urged Janssen to price Olysio lower than current regimens to help address the overall cost of therapy, which continues to spiral out of control.”

The FPC is gravely concerned about the continued precedent this pricing has on the future of HCV therapy. Industry experts have stated their expectations that Gilead Sciences’ new direct acting antiviral, sofosbuvir, will be approved by the FDA in the next few weeks. While the cost of sofosbuvir is not yet known, patients and doctors may look to combine these therapies (off label), resulting in an expected doubling of the current price of therapy.

“We know that this is just the initial price,” said Sandt. “Other HCV protease inhibitor manufacturers quickly increased prices after their initial 2011 launch. For example, a 12-week course of Vertex’s PI Incivek (telaprevir) had a WAC price of $49,000 at launch, but is now priced at $66,155. We caution Janssen not to continue this unacceptable trend. Treatment is just too costly for the majority of people living with chronic HCV,” concluded Sandt, “and we fear that barriers to patient access will be inevitable as a result.”

Anticipating the price of Olysio, the FPC urged Janssen to expand their access programs to ease the fiscal challenges that patients will face when trying to purchase Olysio. The FPC acknowledges that the Johnson & Johnson Patient Assistance Foundation agreed to expand the eligibility criteria for Olysio from 200% to 500% of the Federal Poverty Level (FPL). While this is a step in the right direction, it is not as generous as the program Vertex established for their PI, which is a maximum household income of $100,000 per year. The FPC also applauds Janssen’s intent to initiate a $25,000 per course of treatment co-pay program for Olysio. Unfortunately, the legal status of such programs for the Qualified Health Plans in the new Affordable Care Act Exchanges remains in question, possibly making Olysio access out of reach for many ACA patients.

“We thank Janssen for responding to our requests to increase the eligibility level of their PAP for Olysio and for developing a generous co-pay assistance program,” said Murray Penner, a member of the FPC. “We know that co-insurance costs will be very high for patients. Despite the access programs Janssen has in place, we are very concerned that the high price of Olysio, coupled with high co-insurance costs for patients, will result in limited access to Olysio.”

Four members of the Fair Pricing Coalition explain how to get help paying for your HIV medications. The bottom line? Apply for programs even if you don’t think you qualify, be persistant and don’t give up!

“This is a long-anticipated addition to the options available to people living with HIV/AIDS and their healthcare providers”, said Lynda Dee, FPC spokesperson. “However, in pricing the new drug more than 35% above the $21,000 per year WAC price of its own best-selling single-tablet regimen, Atripla™, Gilead has created an environment of restricted access and financial hardship for patients impacted by current dire economic conditions and US healthcare costs and whose very lives depend on access to more convenient treatments,” Dee added.

Gilead appears to be pricing cobicistat, its own booster component of Stribild™, comparably with Abbott Laboratories’ Norvir™ which includes Abbott’s unconscionable 400% price increase while its closest competitor Merck & Co.’s integrase inhibitor Isentress™, plus Truvada™ needs no booster and has an annual WAC price of $26,200. Thus, Stribild’s™ booster component cobicistat is more like excess baggage than an achievement worth $2,000 above the only other approved integrase inhibitor combination. There may also be a greater risk of kidney side effects with Stribild™ than with the Merck integrase inhibitor combination.

“Gilead asked for community input in setting the price of its new product, and invited the FPC to the negotiating table in June for discussions,” said Dee. “We thought we had reached a reasonable understanding with Gilead, but evidently the company is more interested in filling its coffers than in reasonable and fair pricing. I’m shocked at the price they have set, and would call this a betrayal of the spirit of our negotiations“, she added. “We will now consult with our community partners, government allies as well as public and private payers to determine the best course of action to take,” she concluded.

The Fair Pricing Coalition has written in protest of Gilead’s constant and excessive price increases for their HIV drugs and is asking others to sign onto our protest letter. The letter and signatories as of 3/19 are below. If you’d like to add your voice click here.

We are writing in response to your latest antiretroviral price increases. We are dismayed that Gilead has imposed a 7.9% price increase on Truvada and agreed to a 7.3 % increase on Complera and a 6.6% increase on Atripla in January of 2012. Because the Fair Pricing Coalition (FPC) has been unable to convince Gilead to take no more than one annual price increase in line with the Consumer Price Index (CPI), we have enlisted the assistance of the larger HIV community in this effort.

We have been urging Gilead to refrain from taking more than one annual price increase no greater than the CPI for many years. In October of 2009, the FPC wrote to our industry partners, including Gilead, about the crisis in access to HIV medication, resulting, in part, from repeated industry price increases taken continuously over a short period of time. Gilead has constantly been one of the worst offenders in this regard.

While we salute Gilead for its commitment to AIDS Drug Assistance Programs (ADAPs) as well as its co-pay and Patient Assistance Programs (PAPs), we are astounded at how Gilead diminishes the benefit of its philanthropy with these continuous price increases. It is essential that you understand the negative impact of your actions on people living with HIV/AIDS (PLWHAs). Since our original 2009 letter, Gilead has raised prices three times each for Viread and Truvada for a total of 22.1% and 24.5% respectively; twice for Emtriva for a total of 15.3%,and agreed to four price increases on for Atripla, totaling 21%, and agreed to a 7.3% price increase for Complera. These increases are dramatically higher than the rate of inflation. They also come at a time when many people with HIV have lost their jobs, their employer-based insurance coverage and, in many instances, their ADAP coverage, all resulting in desperate patients attempting to access HIV drugs on the open market, a market plagued with constantly increasing drug prices.

As U. S. economic stagnation persists, PLWHAs continue to lose jobs, income, health care benefits and ADAP coverage. At the same time, third party payers are imposing higher premiums as a direct result of escalating drug prices. Some patients have abruptly stopped treatment because they can no longer afford their medications. Although PAPs exist to help people who cannot afford medication, barriers to access are significant. Many people are unaware of the existence of PAPs. Others cannot cope with the labyrinth of multiple forms and requirements. Even with Gilead’s PAP eligibility at 500% of the Federal Poverty Level, a PLWHA earning $56,000.00 annually is not PAP eligible and will have to pay $20,000.00 or more to purchase Atripla at retail prices. This figure represents at least two-thirds of their net income.

The pharmaceutical industry’s extravagant price increases reverberate throughout the healthcare industry. They come at a time when many ADAPs are covering private insurance payments for their clients and result in ADAPs paying significantly increased premiums as a result of exorbitant price increases. This policy also results in higher premiums for people with HIV who are insured at a time when more and more people have less and less income due to unemployment, underemployment, reduced wages and reduced hours. Moreover, higher healthcare costs mean higher co-pays and pharmacy deductibles for people with private insurance and high share-of-cost plans which also result in increased costs to patients as well as decreased benefits. More restrictive access within insurance plans affects the cost of drugs, but also ancillary services, such as mental health, prevention healthcare, rehabilitation and substance abuse services.

Escalating costs for private and employee healthcare plans occasioned by continuous drug pricing increases will undoubtedly have a deleterious effect on the states as they design their health care exchanges in preparation for the 2014 implementation of the Affordable Care Act (ACA). Many states are likely to set a minimum standard for drug coverage for their “essential health benefits” package that requires only limited coverage of antiretrovirals and other higher cost drug classes. Additionally, with non-preferred generic antiretrovirals entering the marketplace we are concerned that higher drug prices will increasingly result in key coverage decisions being driven by cost rather than the standard of care for HIV treatment.

From our perspective, much of this crisis is occasioned by irresponsible pharmaceutical industry behavior. We firmly believe that Gilead’s price increases are particularly egregious because Gilead currently has the lion’s share of the antiretroviral market.We believe that the best way to begin to address these issues is for industry to change its price increase practices and agree to the following:

Gilead must agree to take no more than one CPI consistent price increase annually.

Gilead must use its sales force to disseminate information regarding its PAP and co-pay programs.

Gilead must contribute to foundations that provide co-pay program access to Medicare Part D clients.

Gilead must cooperate with the FPC and other stakeholders in designing and implementing a seamless, industry-wide standardized PAP criteria and enrollment process.

Now is the time for Gilead to reconsider its price increase policy and rescind its latest unreasonable price increases. We sincerely hope that Gilead will agree to the above and we look forward to your immediate response.

Yours truly,
The Fair Pricing Coalition and the Undersigned Organizations

On May 23, 2011, the FDA approved Vertex’s Incivek (telaprevir), the second new drug for the treatment of hepatitis C virus (HCV) infection to come to market in almost ten years. Merck’s Victrelis (boceprevir) was approved by the FDA on May 13, 2011. The United States Department of Health and Human Services estimates that there are between 2.7 to 3.9 million people in the United States living with HCV and that approximately 20,000 people are newly infected with HCV every year.

“While this new drug approval is another very exciting development for the HCV community, the Fair Pricing Coalition (FPC) is appalled at the price set by Vertex for Incivek,” said FPC member Lynda Dee. “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $49,200 per 12 week course of Incivek treatment will adversely affect the ability of people with HCV to access this new drug and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline.

“Merck’s Victrelis costs $48,400 for 48 weeks of treatment. Now Vertex has set a price approximately four times greater than Victrelis for twelve weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”

Like Victrelis, Incivek is a drug from the protease inhibitor family that is relatively easy and uncomplicated to make. “We understand that drug development costs a lot of money, and we commend Vertex for their excellent Incivek drug development program, but there is no reason for a drug from the protease inhibitor class to be so expensive,” said Dee.

The FDA label recommends that 12 weeks of Incivek be taken with pegylated interferon and ribavirin for either 24 or 48 weeks, depending on a patient’s response to the regimen. The WAC price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is approximately $30,000. The $49,200 WAC price for 12 weeks of Incivek will more than double the already exorbitant 48 week price of pegylated interferon and ribavirin.

“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current US healthcare crisis,” said Dee.

“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.

“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”

A recent paper presented at the American Association for the Study of Liver Diseases conference indicates that there will be a 30% increase in the cost of treating side effects caused by use of the new HCV protease inhibitor drugs. “These increased costs must also be considered in the equation,” said Penner.

“Many people with HIV are also co-infected with HCV,” said Bill Arnold of the FPC. “The cost of HIV drugs which must be taken over the entire course of a patient’s life, plus a course of this new HCV treatment is unreasonably excessive. At this time, there are over 8,300 people on waiting lists for federally funded AIDS Drug Assistance Programs (ADAPs). I am very concerned that these people will never gain access to promising new HCV therapies. Many may die as a result.”

Many individuals with HCV also have other medical conditions such as diabetes and bleeding disorders, and people with bleeding disorders pay as much as $150,000 each year for their clotting factor drugs alone. While many do have private insurance, the cost of co-pays and caps on insurance coverage may make these promising new therapies unaffordable for many people with private insurance, resulting in the inability of even people with insurance to access promising new HCV therapies.

“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” said Dee. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.

“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”

May 17, 2011—On May 13, 2011, the FDA approved Merck’s Victrelis (boceprevir), the first new drug for the treatment of hepatitis C virus (HCV) infection to come to market in almost ten years. The United States Department of Health and Human Services estimates that there are between 2.7 to 3.9 million people in the United States living with HCV and that approximately 20,000 people are newly infected with HCV every year.

“While this new drug approval is a very exciting development for the HCV community, the Fair Pricing Coalition (FPC) is very disappointed at the price set by Merck for Victrelis,” said FPC member Lynda Dee. “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $1,100 per week will adversely affect the ability of people with HCV to access Victrelis and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline. You can bet that no future HCV drugs will be priced less than Victrelis. This is a very bad start.”

Victrelis is a drug from the protease inhibitor family that is relatively easy and uncomplicated to make. “We understand that drug development costs a lot of money, but there is no reason for a drug from the protease inhibitor class to be so expensive,” said Dee.

Two other drugs, pegylated interferon and ribavirin must be taken with Victrelis, and the WAC price for HCV treatment with these two drugs is approximately $30,000. The FDA label recommends that Victrelis be taken with pegylated interferon and ribavirin for either 24, 32 or 48 weeks, depending on a patient’s response to the regimen. The WAC price for Victrelis is $26,400 for 24 weeks, $35,200 for 32 weeks and $48,400 for 48 weeks of treatment.

“These amounts added to the already high $30,000 cost of pegylated interferon and ribavirin make the cost of the new Victrelis containing regimen astronomical,” said Dee. “Although the addition of Victrelis to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current US healthcare crisis.”

“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis. If each of the new drugs costs approximately $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”

A recent paper presented at the American Society of Liver Diseases conference indicates that there will be a 30% increase in the cost of treating side effects caused by use of the new HCV protease inhibitor drugs. “These increased costs must also be considered in the equation,” said Penner. “Many people with HIV are also co-infected with HCV,” said Bill Arnold of the FPC. “The cost of HIV drugs which must be taken over the entire course of a patient’s life, plus a course of this new HCV treatment is unreasonably excessive. At this time, there are over 8,100 people on waiting lists for federally funded AIDS Drug Assistance Programs (ADAPs). I am very concerned that these people will never gain access to promising new HCV therapies. Many may die as a result.”

Many individuals with HCV also have other medical conditions such as diabetes and bleeding disorders, and people with bleeding disorders pay as much as $150,000 each year for their clotting factor drugs alone. While many do have private insurance, the cost of co-pays and caps on insurance coverage may make these promising new therapies unaffordable for many people with private insurance, resulting in the inability of even people with insurance to access promising new HCV therapies.

“We are very disappointed by the cost set by Merck for Victrelis and are even more concerned that Vertex’s Incivek (telapravir) which will probably be approved by the FDA later this month may be even more expensive,” said Dee. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.

“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”

The Fair Pricing Coalition (FPC) today announced that it has brokered agreements that will allow approximately 6,500 Floridians to continue to receive their HIV medications during a budget crisis in that state. Partners in the agreement include Welvista, a non-profit pharmacy; major manufacturers of HIV medications; and the State of Florida’s AIDS Drug Assistance Program (ADAP). Florida’s ADAP was expected to exhaust all available funds and shut down in early February if an emergency solution was not implemented. With these agreements, the state of Florida projects having enough funds to provide medications to its remaining 3,500 ADAP clients for the remainder of the ADAP fiscal year (through March 31, 2011). The plan will be final when the state of Florida and Welvista sign their operational agreement, expected to occur in the next several days.

Under the plan, Florida’s ADAP will transition approximately 6,500 of their nearly 10,000 active clients to Welvista beginning February 14, 2011. Welvista will provide up medications to these clients as a “transition” to the next ADAP fiscal year which begins April 1, 2011, when Florida’s renewed allocation of federal Ryan White/ADAP funds becomes available. Clients will then again receive their medications from Florida’s ADAP program.

Abbott Laboratories, Bristol-Myers Squibb (BMS), Gilead Sciences, Merck and Co., Tibotec Therapeutics and ViiV Healthcare already participate with Welvista to expedite access to HIV medications for ADAP clients on waiting lists. Abbott, BMS, Gilead and Merck and ViiV have agreed to participate in the plan brokered by the FPC and will provide medications to Welvista for these additional clients in Florida on a one-time, emergency basis. The FPC is still negotiating with Tibotec Therapeutics about this situation.

“None of us are happy with the Florida fiasco,” remarked Lynda Dee, spokesperson for the FPC. “It will result in a drain on limited funds from drug company patient assistance programs (PAPs). This inequitable use of industry PAPs could have a very significant, negative impact on the ability of other patients from other states to utilize these PAPs,” Dee warned.

“We are nonetheless grateful to the companies and Welvista for their willingness to step in to provide medications for Florida patients,” said Dee. “We clearly recognize this is a one-time, emergency rescue of a program that cannot be repeated or duplicated by Florida or any other state. We therefore implore the federal government and all state governments, especially Florida, to provide adequate funding to state ADAPs to meet the medication needs of its uninsured and underinsured people living with HIV,” she concluded.

Nationally, state ADAPs are situated in the eye of a “perfect storm.” Thousands continue to enroll in state ADAPs each year due to the effects from the economic recession, and other factors are contributing additional pressure. These include rising drug prices on already-expensive medications (some companies have agreed to price freezes for ADAPs while others continue to take price hikes, limited by law for ADAPs to be no more than the rate of inflation); minimal increases in federal appropriations (the federal ADAP contribution has shrunk from approximately 70 percent to 50 percent of the overall national ADAP budget in recent years) and significant state budget cuts; and larger client caseloads due to HIV-positive individuals living longer. Positive developments such as national efforts to significantly expand HIV testing and linkages into care and new HIV treatment guidelines calling for earlier therapeutic treatments have further pushed ADAPs to a fiscal tipping point from which recovery will be difficult.

The National Alliance of State and Territorial AIDS Directors (NASTAD) reports that as of January 27, 2011, there are 5,779 individuals on ADAP waiting lists in ten states. Twenty states have instituted, or anticipate instituting cost containment measures other than ADAP waiting lists before the end of the ADAP fiscal year ending in March 2011. Florida has the greatest number of individuals on its waiting list (3,008) which will continue into the next fiscal year. Those individuals are, for the most part, already receiving medications through other pharmaceutical patient assistance resources, and are not affected by this plan. To see a list of states with access restrictions, please visit NASTAD’s website at www.NASTAD.org.

The FPC remains concerned about the fiscal health of Florida’s and many other state ADAPs. Moving forward, the FPC will work with local advocates to push Florida for additional state appropriations and to seek drug rebates that should have been applied for heretofore. In addition to working on this stopgap measure to ensure uninterrupted medications for 6,500 Floridians, the FPC will also continue to work with all stakeholders and ADAPs on long-term solutions to the national ADAP crisis.

About the Fair Pricing Coalition (FPC): The FPC is a group of community treatment activists advocating for fair and sustainable pricing of HIV and viral hepatitis drugs in the United States. The FPC also works with manufacturers of HIV medications to ensure adequate co-pay and patient assistance programs are in place to help ensure all Americans living with HIV have access to life-saving medications.

About Welvista: For over 17 years, Welvista, a nonprofit organization located in Columbia, South Carolina, has been providing access to prescription medications to the uninsured and underserved throughout South Carolina. Welvista partners with 12 branded pharmaceutical companies who donate medications and a network of over 3,000 health care providers, making them one of the largest mail-order pharmacies for the uninsured in the nation. In 2009, Welvista filled and dispensed more than 135,000 prescriptions to the uninsured valued at over $47 million. With a grant from the Heinz Family Philanthropies and Abbott Laboratories, Welvista began serving ADAP waiting list clients as part of its mission in August, 2010. For more information, visit www.welvista.org.